FORM 2
THE PATENTS ACT. 1970
(39 of 1970)
&
THE PATENS RULES, 2003
PROVISIONAL SPECIFICATION
[See section 10, Rule 13]
DISPENSING AID;
CIPLA LIMITED, A COMPANY INCORPORATED UNDER THE INDIAN COMPANIES ACT, 1913, WHOSE ADDRESS IS 289, BELLASIS ROAD, MUMBAI CENTRAL, MUMBAI - 400 008, IN THE STATE OF MAHARASHTRA, INDIA;
THE FOLLOWING SPECIFICATION DESCRIBES THE NATURE OF THIS INVENTION.


FIELD OF THE INVENTION
The present invention relates to an inhalation device for inhalation of medicaments, and to a holder for such medicaments.
BACKGROND OF THE INVENTION:
Dry powder inhalation (DPI) devices are generally used for inhalation of
powdered medicament from capsules. The DPI devices may either single
dose or multidose. In the single dose or multiple unit dose DPI
formulations, the drug is pre-packaged in capsules or blisters. The
reservoir DPI formulations involve a device containing at least a reservoir
and a metering chamber to administer an accurate dose of the drug.
Medicament holders, particularly for inhalation devices known in the art
are used for receiving and holding a medicament in granular form or
powder form, or volatile form or in a capsule containing powdered or
volatile medicament. The configuration of the holder is such that the
medicament or the capsule located inside the chamber is rotated or
moved up and down by air flowing through the chamber in order to
disperse the powdered drug medicament into air being sucked.
The medicament holders, for example capsule chambers, known in the art
are generally tubular or cylindrical in shape with an air inlet and air outlet
arranged coaxially at the bottom and top ends respectively. The air inlet is
generally smaller and outlet opening generally larger than the diameter of
the capsule. A mouthpiece is arranged axially to the air outlet. Generally, a
piercing mechanism is provided to pierce the capsule to enable the
medicament present in the capsule to be inhaled. During inhalation, air
passes from the air inlet and causes movement of the capsule, and due to
this, the medicament present in the capsule is carried by the air to the air
outlet opening and mouthpiece and reaches the patient's lungs.
Single dose DPI devices working with capsules, usually possess a system
to pierce the capsule. After piercing, the patient inhales the powder
contained in the capsule through the device without swallowing the
capsule. The capsule remains in the device, which is discarded from the
device prior to the next use of the device.
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WO 91/06333 describes a device for dispensing single doses of a
powdered medicament from a container having a plurality of apertures,
each of which holds a respective one of said doses, and is sealed by two
opposed seals. The device comprises a housing for holding the container,
the housing having an outlet and an airway, which communicates with the
outlet and being configured to allow the container to move relative thereto
to bring each aperture in succession into registry with the airway. The
device includes a piercing member movable from a retracted position in
which it is positioned clear from the container into an extended position in
which it extends into the aperture, said movement causing rupture of the
seals, while expelling substantially no medicament from the aperture.
US Patent No 5,685,294 discloses an inhaler for inhalation of powdered
medicament, more particularly a microionised drug preparation, from
capsules, the housing of the inhaler comprising tubular chambers for
receiving and holding medicament-containing capsules in a revolver
magazine with an air inlet at the bottom and an air outlet at the opposite
end of the chamber opening into a mouth piece, a cutting device with two
blades which are movable into the interior of the chamber in order to open
the capsules near the top and bottom ends thereof.
US Patent No 3,807,400 discloses an inhaler comprising an upper
member comprising a whirling chamber; a lower member comprising a
capsule-receiving chamber and a series of cams and recesses on the
inner wall of the lower member; and piercing members resiliency biased
away from a capsule received in the capsule-receiving chamber by the
action of a spring. In use, rotation of upper and lower members relative to
each other causes reciprocations of the piercing members against the
cams and recesses provided on the inner wall of the lower member, so as
to effect a number of diametrically opposed piercing operations on the
capsule.
US Patent No 3,795,244 discloses an inhaler comprising a housing; a
rotary member located within the housing and having at one end
engagement means adapted to receive a medicament-containing capsule;
and a piercing assembly comprising opposed arms with piercing pins
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mounted thereon and a tubular member slidable relative to the housing and having cam projections from the inner wall. In use, and prior to inhalation, the user inserts a capsule into the engagement means and is then required to manually slide the tubular member towards the mouthpiece, so that the cams provided on the inner wall of the tubular member push opposed piercing arms towards the capsule, resulting in perforation of the capsule at its free end. The user is then required to manually return the tubular member to its original position, allowing the piercing arms to return to the non-piercing position. US Patent No 4,069,819 discloses a dry powder inhaler device comprising a nebulising chamber adapted to receive a medicament-containing capsule. A capsule received in the chamber is freely moveable within it. In use, air flow through the nebulising chamber and around the capsule contained therein causes the entire capsule to move within the nebulisation chamber.
US Patent No 3,635,219 discloses a dry powder inhaler device comprising a propeller-like member rotatably mounted in a housing and having mounting means adapted to receive a medicament-containing capsule. In use, flow of inhaled air through the device causes rotation and vibration of the propeller-like member and a capsule mounted thereon, so dispensing medicament into the air stream. The device further comprises spring-loaded piercing members mounted in the housing so as to be normally urged into an inoperative position but which may be manually pushed inwards to perforate a medicament containing-capsule received in the device by the action of pushbuttons or sliding cams. US Patent No 3,906,950 describes a dry powder inhalation device comprising a swirl compartment and, separately, a capsule-receiving cavity comprising two components, said cavity slidably attached to a pair of relatively moveable elements which hold piercing needles and which telescopically slide inside capsule holder components against the action of a pair of return springs. US Patent No 5,947,118 relates to a capsule holder for receiving two part
capsules, which holder comprises a recess adapted to receive a capsule,
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wherein the sidewalls of the recess have three or more ribs arranged parallel to the central axis of the recess between which capsules can be clamped by both upper and lower parts with some deformation of the capsule walls. The relative dimensions of the cylinder defined by the ribs and the capsule is such that in use, a capsule received by the ribs is clamped and held firmly in place within the holder. US Patent No 4,889,114 discloses a dry powder inhaler device comprising a capsule-receiving chamber comprising an air inlet and an air outlet located at opposed ends of the chamber. In use, air flow through the chamber on inhalation causes movement of a capsule received therein, between the air inlet end and the air outlet end of the capsule-receiving chamber. The capsule is freely moveable within the confines of the chamber.
All the known inhalation devices require the user of the device to open the device, insert a medicament-containing capsule, close the device, and pierce the capsule manually by a pushing or rotating action prior to inhalation of the medicament. The user has to perform numerous actions before actual inhalation of the medicament.
We have found that the known medicament holders also have the disadvantage of requiring the user of the inhaler to inhale very deeply in order to try to inhale the full dose of the medicament.
DESCRIPTION OF THE INVENTION
One improved inhaler is described in our application WO 2006/051300.
We have now made further improvements over the known devices and
holders.
In its broadest aspect, the present invention provides an inhaler device for
inhalation of a medicament from a pierceable capsule, which inhaler
comprises a housing for receiving a medicament capsule; closure means
for closing the housing, said closure means being moveable relative to the
housing; piercing means suitable for piercing a medicament capsule;
wherein movement of the closure means relative to the housing causes
movement of the piercing means; and wherein the device comprises an air
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inlet and an air outlet defining an inhalation passage therebetween, the
passage comprising one or more vents.
In another aspect of the present invention, there is provided an inhaler
device for inhalation of a medicament from a pierceable capsule, which
inhaler comprises a housing for receiving a medicament capsule; closure
means for closing the housing, said closure means being moveable
relative to the housing; piercing means suitable for piercing a medicament
capsule; and linking means connected to both the closure means and the
piercing means, wherein movement of the closure means causes
movement of the linking means so as to move the piercing means; and
wherein the device comprises an air inlet and an air outlet defining an
inhalation passage therebetween, the passage comprising one or more
vents.
Thus, in use, piercing or perforation of a capsule received in the housing
occurs as a consequence of merely closing the housing subsequent to
having placed a medicament-containing capsule therein. The user is not
required to perform any additional actions prior to inhalation of
medicament from the inhaler device, other than inserting a capsule and
closing the device.
Preferably, the medicament contained within the capsule is a dry powder
medicament. The term capsule is intended to be understood broadly and
includes any suitable receptacle for medicament. The capsule may be
formed from any suitable material, including gelatin, HPMC, or plastic.
The device may be made from any suitable material. Preferably the
device is made of plastic, for example ABS (acrylonitrile butadiene
styrene), PC (polycarbonate), PA (polyacetal) or PS (polystyrene), or
mixtures thereof, or of an antistatic material such as delrin.
We have found that the inclusion of one more vents enables the patient to
inhale more easily, because of a reduced resistance to air flow.
It will be appreciated that the inhaler device will comprise at least one
main air inlet through which air is initially drawn from the atmosphere into
the device. Likewise, the device will also comprise a final air outlet
through which inhaled air exits the device and enters the patient's mouth.
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Between this initial air inlet and final air outlet, the device will define a passageway through the body of the device through which air flows. The passageway is referred to herein as the inhalation passage. The invention provides one or more vents, which it will be understood are essentially auxiliary air inlets, positioned at one or more points along the inhalation passage. The vents are essentially small openings in the wall of the inhalation passage, which serve to connect air in the inhalation passage with air external to the passage.
Preferably, two vents, which suitably oppose each other, are employed, although one vent, or more than two vents may be employed if desired. The vents can be of any suitable shape and size, although they are preferably crescent-shaped. The overall size of the vents must be such that a reasonable flow of air still flows through the housing or holder containing the medicament capsule, such that the targeted amount of medicament is available to the patient.
It is preferred to position these vents upstream of the medicament capsule, relative to the flow of air through the inhalation passage. The closure means can be moveable relative to the housing in any suitable way. The closure means is typically connected to the housing, although they may, if desired be separate parts. Suitably, the closure means is adapted to, or comprises suitable means for, producing movement of the piercing means so as to cause piercing of a capsule. Preferably, the closure means is rotatable relative to the housing. For example, the closure means may be pivotally connected to the housing. Preferably, movement of the closure means causes movement or rotation of a linking means. In one embodiment, rotation of the closure means drives linear displacement of the piercing means. However, the movement of the piercing means is not limited and the piercing means may move in any way, so long as the object of piercing a capsule is achieved. For example, we envisage rotary motion of the piercing means as a possibility. The movement of the closure means preferably moves the piercing means
so as to pierce a capsule positioned within the inhaler housing. Suitably,
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movement of the closure means from a fully open or fully closed position
drives movement of the piercing means from a fully retracted position.
The piercing means preferably moves from a fully retracted position to a
fully extended piercing position and back to a fully retracted position in
response to movement of said closure means between the fully open and
fully closed piercing positions.
The housing preferably comprises means to hold a medicament capsule,
said holding means preferably comprising a chamber having one or more
air inlets and air outlet(s). The air inlet of the chamber may constitute the
air inlet of the device, or the air inlet of the device may be provided
separately on the device, for example elsewhere on the housing. The or
each air inlet and outlet are preferably provided at opposing ends of the
chamber. In a preferred embodiment, the or each air inlet is positioned in,
or near to, the base of the medicament holder. They may, for example, be
provided on the walls of the chamber, for example on the lower walls. The
flow of air via the or each inlet may be at a tangent to, or at an angle offset
from, the longitudinal axis of the chamber. In one embodiment, a single air
inlet may be used. Alternatively, two or more inlets may be used. For
example, two air inlets may be provided at or near the bottom of the
holder. Preferably, they are provided in the lower vertical walls of the
chamber. For example, two inlets may be provided substantially opposite
to one another in the lower walls. These inlets may, if desired, be offset
from one another; for example in a tangential arrangement.
The interior of the chamber may be of any suitable shape and dimension.
It may, for example, define a single cavity of uniform dimensions
Alternatively, the interior of the chamber may comprise one or more steps
such that the internal cavity is non-uniform. One additional step in the
interior of the chamber is preferred. The or each step is preferably
substantially perpendicular with the respect to the longitudinal axis of the
chamber, although any suitable angle may be employed.
The closure means preferably comprises a mouthpiece. That is to say,
the closure means is preferably such that it includes means by or via
which medicament may be inhaled from the device by the user. In what
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follows, the invention is described with reference to a device wherein the
closure means comprises a mouthpiece, it being understood that the
invention includes embodiments wherein the closure means may not
necessarily comprise or include a mouthpiece. For example, the closure
means and mouthpiece could be separate. Thus, in what follows, it is to
be understood that references to a mouthpiece may be substituted with
references to closure means. The inhaler mouthpiece is preferably
pivotably attached to the housing.
The air outlet of the medicament chamber is suitably positioned so as to
connect or coincide with the mouthpiece in its fully closed position. For
example, the mouthpiece may suitably comprise means to receive air from
an outlet of the medicament chamber, such that when the mouthpiece is
closed the means for receiving air is connected with, or cooperates with,
the outlet. Any suitable means may be used, for example a tube, which
may for example be cylindrical. Conical means may be used. The means
may be formed as an integral part of the mouthpiece or may be a separate
part. Suitably, the means (e.g. a tube which may be cylindrical or oval
shaped in cross section) comprises one end which connects with the
outlet of the medicament chamber, and another end which comprises an
outlet for the medicament, from which outlet medicament is inhaled by the
user. It is preferred that the end which connects with the outlet of the
medicament chamber comprises the vents, preferably two opposing
crescent-shaped vents positioned at either side. The arrangement is
preferably such that the vents are in close proximity to the outlet of the
medicament chamber. The outlet of the said means may constitute the
final air outlet of the inhaler device. Preferably, the positioning, in
particular the angle, of the vents is such that in use the direction of airflow
through the vents is in the same general direction as the direction of the
main inhalation airflow through the inhalation passage. It will be
understood the vents are typically formed as a hole or opening through the
thickness of one or more walls of the inhalation passage. Where the wall
thickness is such that an axis through the vent can be defined, the axis of
the vent is preferably at an angle of less than 90 degrees, more preferably
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45 degrees or less, relative to the direction of the main inhalation airflow
through the inhalation passage. That is to say, the flow of air through the
vents into the inhalation passage is preferably not perpendicular to, or
against, the main inhalation flow, but flows in the same general direction.
The portion or means of the mouthpiece adapted to receive air (for
example the tube described above) from the medicament chamber is
preferably of an optimised length. Preferably, the length is between about
25 and 35mm. We have found a length of 31.6 mm +/- 10 % to give very
good performance. Suitably, two crescent -shaped vents may be
positioned one at either side of the tube at a distance of about from 4 to
6mm, ideally about 5mm, from the end of the tube which cooperates with
the outlet of the medicament chamber.
The mouthpiece is preferably provided with a mesh, which is
positioned in proximity to the chamber outlet when the mouthpiece is in a
fully closed position. Preferably, the mesh is provided on a means for
receiving air from the outlet of the chamber. Preferably, the mesh is on, or
near to, the end of the said means (for example, a tube), such that the
mesh is brought into proximity with the outlet of the medicament chamber
when the mouthpiece is in the closed position. The mesh may be
provided as a separate part or as an integral part of the device. A mesh
may if desired also, or alternately, be provided on or close to the outlet of
the medicament chamber. Again, the mesh may be an integral or a
separate part. The primary function of the mesh is to prevent the capsule
or fragments thereof from being inhaled by the user. The vents are
preferably positioned in proximity to the mesh.
The device preferably further comprises locking means. The locking
means suitably locks the closure means, for example the mouthpiece, in a
predetermined position relative to the housing. Preferably, the locking
means is operable to retain said closure means in the fully closed position.
The locking means may provide a rigid pivot for the opening and closing of
the device. Alternatively, the locking means may comprise a lip or suitable
projection on a portion of the capsule holder adapted to be received by a
portion of the closure means, for example to provide a snap-fit. Preferably,
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the arrangement is such as to secure or lock the mouthpiece in the closed
position.
The piercing means may be any suitable means but preferably comprises
one or more piercing pins and/or one or more blades, although piercing
pins are most preferred. The piercing means (suitably pins) may be of any
suitable material, and are preferably metallic. For example, stainless steel
may be used.
The device preferably further comprises guide means to guide the
movement of the piercing means. For example, the guide means may
comprise one or more tubes extending from an external part of the
medicament chamber. One or more suitable holes may be provided in the
chamber, the arrangement being such that the guiding means serve to
guide the piercing means through the said holes so as pierce a capsule.
The mouthpiece (3) preferably coincides with the outlet (12) of the capsule
holder (2) so as to receive the medicament during inhalation. Preferably,
a link actuator (4) adapts the link (5) to the mouthpiece (3) in such a
manner that the link actuator (4) rotates on rotation of the mouthpiece
enabling the piercing pins (7) move laterally.
In another embodiment of the present invention, a link actuator may be
replaced or substituted by a link member or a horse-shoe shape member,
or any suitable alternate embodiment which serves to move the piercing
pin(s) on opening/closing of the mouthpiece.
Another embodiment of the present invention provides a method for
piercing a capsule or similar suitable medicament receptacle in an inhaler
device according to the present invention.
In the following description the terms housing and lower body are used
interchangeably.
In one aspect, the present invention provides an inhalation device
comprising a lower body (1) having a medicament or capsule holder (2) to
hold the capsule or similar suitable medicament receptacle; a mouthpiece
(3) laterally pivoted to the lower body (1) to rotate about an axis; a link
actuator (4) adapted to rotate on rotation of the mouthpiece (3) and being
held in the lower body (1); one or more piercing pins (7) for piercing
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capsules or similar suitable medicament receptacle and being adapted to
a link (5); characterized in that the mouthpiece rotates the link actuator (4)
that moves the piercing pin(s) linearly to pierce the capsule or similar
suitable medicament receptacle in a partial open/closed position of the
mouthpiece; and wherein the device comprises an air inlet and an air
outlet defining an inhalation passage therebetween, the passage
comprising one or more vents.
An inhalation device according to the present invention (as shown for
example in Figures 1, 2, and 3) generally comprises a lower body (1)
having a capsule holder (2) for holding capsules or similar suitable
medicament receptacle (10); said capsule holder (2) having an air inlet
(11) and an outlet (12); a mouthpiece (3) pivoted laterally to the lower
body (1) so as to rotate about an axis and thereby open and close the
outlet (12) of the capsule holder (2). The capsule holder (2) is preferably
adapted to receive one or more piercing pins (7) that are held in retracted
position in a piercing pin holder (6). The piercing pins (7) are operated by
a link (5) that enables the linear movement of the piercing pin (7) to pierce
the capsule or similar suitable medicament receptacle (10) and retract
back.
According to another embodiment of the present invention, the
mouthpiece (3) is opened to place the capsule or similar suitable
medicament receptacle (10) in the capsule holder (2). On opening the
mouthpiece (3) to full open position as shown in Figure 1, the link actuator
(4) rotates the link (5) thereby the piercing pins (7) are retracted. On
closing the mouthpiece (3) for inhalation, in a partially open/closed
position, the piercing pin(s) (7) pierces the capsule or similar suitable
medicament receptacle (10) in the capsule holder (2) as shown in Figure
2. On fully closing the mouthpiece (3), the link actuator (4) rotates and
retracts the piercing pin from the medicament holder (2).
According to another embodiment of the present invention, a cover
member (8) (for example illustrated in Figures 1-3 and Figure 19) may be
attached to the housing or may be moveable relative to the housing. The
cover member may be rotatable relative to the housing. For example, it
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may pivot about the same point as the closure means and housing pivot with respect to each other. The cover member preferably comprises locking means enabling it to lock with the housing. The cover member serves to cover the piercing pin holder, pins, and the link/link actuating mechanism. Preferably the cover member comprises means for locking with the holder when the device is in the assembled state. In another aspect of the invention, there is provided a holder for a medicament, suitably a dry powder medicament capsule, which holder comprises a chamber suitable for receiving a medicament capsule; and means for generating turbulence in a fluid flow through the chamber such that, in use, the turbulent fluid flow causes vibration of a capsule received by the chamber so as to assist in releasing medicament contained within the capsule.
The present medicament holder maximizes the turbulence in the chamber thereby enhancing drug dispersion and delivery.
The means for generating turbulence preferably also holds, or partially holds, a medicament capsule within the holder. Preferably, the means for generating turbulence holds one end of a medicament capsule. Preferably the capsule is held loosely (either completely, partially or at one end). Suitably, this means that any significant movement of the capsule is prevented but the capsule is still enabled to make small vibratory movements within the chamber. The means for generating turbulence may be any suitable means but preferably comprises one or more projections or flow barriers extending from the inner walls of the chamber. The or each projection may, for example, comprise a flat or polygonal facet, or one or more grooves, ridges, helices, rings, or spheres. The means may, for example, comprise one or more transverse, or substantially transverse, projections (relative to the longitudinal axis of the chamber). By polygonal we mean that the projection or barrier presents several faces to the inside of the chamber. For example, in cross section, the means for generating turbulence may be substantially triangular or square, or pentagonal, or hexagonal and so on.
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The holder is preferably such that the diameter of the space defined by the
means for generating turbulence relative to the diameter of a medicament
capsule placed in the holder is such that the capsule is held loosely by the
means for generating turbulence. The chamber may be any suitable
shape, for example cylindrical or conical. Preferably, it is substantially
conical.
Preferably the length of the chamber is optimised. Chamber lengths of
between about 15 to 30mm may for example be used. We have found
particularly good performance with a chamber length of 22 mm +/- 10%.
Preferably, the means for generating turbulence (or flow barrier) is or are
of increased height compared to the means (16) illustrated in Figure 11 of
WO 2006/051300, relative to the axial length of the medicament chamber
(14). Preferably, the means for generating turbulence extends
substantially the entire length of the medicament chamber - that is,
substantially from top to bottom. We have found that increasing the height
of the turbulence - generating means in this way results in reduced
retention of medicament in the chamber. Thus, in a preferred embodiment
the projections (16) illustrated in Figure 11 of the present application
extend to substantially the top of medicament chamber (14), preferably so
that they align with the upper rim of the chamber (14). This is illustrated in
Figure 26, which shows projections (16) extending to the top of the
chamber (14).
The holder suitably comprises one or more openings in the sidewalls of
the chamber. Preferably, one or more of the openings is provided with
guide means for receiving the piercing means, for example one or more
piercing pin. Preferably, the guide means protrudes to the exterior of the
holder.
The holder preferably comprises a chamber provided with an air inlet and
an air outlet. Preferably, the air inlet and air outlet are arranged at
opposing ends of the chamber.
The holder may comprise a mesh, and suitably the mesh is provided in the
vicinity of the air outlet, the mesh preventing the medicament capsule
contained within the chamber to be moved through the air outlet by
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received in the chamber (14) of the capsule holder (2), preventing the
capsule (10) from falling out of the inhaler, or being sucked into the
outlet/mouthpiece on inhalation by the user. The mesh size can be any
suitable size but is preferably of the order of 0.5mm X 0.5mm square to
2mm X 2mm square. More preferably, the mesh size is 1mm X 1mm
square +/- 10%. The capsule holder (2) is also provided with locking
means. The locking means may be used to lock the mouthpiece (3) in a
predetermined position relative to the housing, for example in the fully
closed position, and may be located at any suitable place on the device
The locking means may comprise a lip or suitable projection (32) adapted
to be received by a portion (34) of the mouthpiece (3), which together
cooperate so as to provide a snap-fit when the mouthpiece (3) is closed.
The mouthpiece (3) can thus be secured in the fully closed position.
Figure 2 illustrates the preferred position of the vents, denoted by the
number 70 (the vents themselves are not shown in the drawing). Two
crescent-shaped vents are positioned opposing each other on either side
of the mesh (9). Figure 2 also illustrates the air inlet of the device (71) on
the base of the lower body or housing (1), and the final air outlet (72) on
mouthpiece (3). When the device is in the closed position (as in Figure 3),
the device defines an inhalation passage extending through the device
between inlet (71) and outlet (72). Vents may be placed at any position in
the inhalation passage, although it is preferred to position them upstream
of medicament capsule (10); most preferably they are positioned as
shown in Figure 2. Figure 25 illustrates a preferred position of the vents
(70) relative to mesh (9). The exact positioning can be appreciated with
reference to Figure 27, which shows the position of vents (70) relative to
the mouthpiece (3) and lower body (1).
A preferred embodiment of the capsule holder (2) is shown in Figures 11
to 17. The capsule holder (2) comprises a chamber (14) to receive a
capsule and has an air inlet (11) and air outlet (12). Preferably, the
chamber (14) is cylindrical or substantially conical and the air inlet (11)
and air outlet (12) are located at opposing ends of the chamber (14). A
wall of the chamber (14) is provided with openings (18). When the capsule
20

holder (2) is used in combination with the inhalation device of the
invention, these openings are positioned so as to receive the piercing pins
(7). Guide means (20) extend from the openings (18) to the exterior of the
chamber (14), so as to guide the back and forth movement of the piercing
pins (7) into and out of the chamber (14) in response to rotation of the
mouthpiece (3).
The holder (2) comprises turbulence generating means, for example
projections (16), on the interior wall (12a) of the chamber (14). The
projections (16) have a dual function: they both hold a capsule (10)
received within the chamber (14), and generate turbulence in fluid flow
through the chamber (14) and around a capsule (10) received therein.
When a capsule (10) is received in the chamber (14), the projections (16)
loosely hold the capsule (10) within the chamber (14). During use of the
inhaler, as air is inhaled by the user from the chamber (14) through the
outlet (12) and mouthpiece (3), the projections (16) generate turbulence in
the air flow through the chamber (14). Turbulence in the air flowing around
the capsule (10) causes vibration of the capsule (10) within the chamber
(14), and this vibration enhances the dispersion of medicament contained
within the capsule (10). Accordingly, less forceful inhalation by the user is
required to liberate a full dose of medicament from the capsule (10).
The projections (16) may be of various shapes, such as grooves, ridges,
helixes, rings or spheres, or any other shape suitable for generating
turbulence in a fluid flow.
The capsule holder (2) is provided with holes (28) which enable the holder
(2) to be secured via projections (61) of lower body (1) (see Figure 20)
within an inhalation device. Cooperating means (31) may be provided if
desired to enable cooperation with the piercing pin holder (6): this may
further assist with alignment of the piercing means.
Figures 18 to 24 show various components of a preferred embodiment.
Fig 18 shows a closure means or mouthpiece (3) comprising connecting
means (40) which enable the mouthpiece to connect to cylindrical portion
(58) of link actuator (4) (see Fig 22). Mouthpiece (3) also comprises
opening (57) via which medicament is inhaled by the user. Means to
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receive air (for example a tube) from an outlet of the housing, extends
downwards from opening (57) within the mouthpiece (not shown in the
Figure).
Figure 19 shows a cover member (8) comprising eyes (41) and notch (48).
An equivalent notch is provided on the corresponding side of the cover. In
use notches (48) insert in corresponding recesses (49) on lower body (1)
(see Figure 20), so as to lock the cover member and housing together.
The cover member also comprises a further notch (not shown) on the
underside of the left hand edge: in use this inserts in a corresponding
recess (29) (see Figure 11) so as lock the cover member relative to
capsule holder (2). Eyes (41) enable positioning of the cover around a
(preferably two-piece) pivot (30) (refer to Figure 3) which passes through
eyes (41), eyes (42) of the lower body (1) (see Figure 20), connecting
means (40) of the mouthpiece (3), and opening (45) in link actuator (4)
(see Figure 22) when the device is assembled. In use, the cover (8) is
positioned inside mouthpiece (3).
Figure 20 shows lower body (1) comprising eyes (42) for receiving a pivot
(30), and recesses (49) to receive notches (48) in cover (8) as described
above. (An equivalent recess (49) (not shown) to that illustrated in Fig 20,
is provided on the corresponding side of the housing (1).) The sides (50)
of lower body (1) are suitably adapted to receive capsule holder (2).
Figure 21 shows link (5) comprising two arms comprising eyes (43) and
end portion (44) supporting notches (51) (only one notch is shown) on
either side. The eyes (43) cooperate with corresponding notches (55) on
pin holder (6) (see Figure 23) and thus enable movement of the piercing
means (7) when the link (5) is driven by link actuator (4). Notches (51) are
received by eyes (46) on link actuator (4), and are rotatable relative to the
said eyes (46).
Figure 22 shows link actuator (4) comprising substantially cylindrical body
(58), which is extended via arms (47), which terminate in eyes (46). The
actuator (4) also comprises square hole (45), which receives a
corresponding sized square pivot (not shown). Correspondingly square
holes (60) in connecting means (40) of mouthpiece (3) enable the link
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actuator (4) and mouthpiece (3) to be rigidly connected (that is, not rotate with respect to each other). In this way, movement of the mouthpiece (3) relative to the housing (1) enables movement of piercing means (7) via driving of link (5).
Figure 23 shows piercing pin holder (6) comprising notches (55), as described above, and cylindrical tubes (54) which are adapted to receive attachment means (31) which project from capsule holder (2) (refer to Fig 11). The cylindrical attachment means (31) are slideable within the tubes (54). In use, pins (7) are mounted in holes (53) (one is obscured in Fig 23). The pins (not shown in Fig 23) project beyond tubes (54) and are slideably received within guide means (20) of capsule holder (2). Figure 24 shows a preferred piercing means, which is a cylindrical pin (7). Preferably, the piercing end of pin (7) comprises a face (56) formed by an oblique cut through the shaft of the pin. Further modification of the piercing end may also be made to achieve the desired shaped point. The pins may be any suitable size. They may be in a range between 1 mm to 2 mm in diameter, although we prefer to use pins with a diameter of about 1.5mm+/-10%.
The capsule or medicament holder described is not limited to the embodiments described, and includes various means and forms that may be provided for maximising the turbulence by providing suitable means for generating turbulence in the medicament holder.
Dated this 16th day of June, 2006.
FOR CIPLA LIMITED By their Agent
(GIRISH VIJAYANAND SHETH) KRISHNA & SAURASTRI
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